Combination products, including prefilled syringes, autoinjectors, on-body/wearable systems, or drug-device diagnostic pairings, are among the most complex programs to develop because they must satisfy drug/biologic and device requirements simultaneously. Success depends on getting the interfaces right: formulation and container/closure compatibility, extractables/leachables, human factors and usability, design controls, and a quality system that can withstand scrutiny across both worlds. As regulatory expectations continue to evolve, teams can lose time in rework, conflicting interpretations, or misaligned development plans.
Pharmatech Associates, a USP company, partners with you to simplify that complexity with an integrated approach across CMC, device and drug quality systems, human factors, and regulatory strategy. We bring proven models for aligning drug and device development plans, integrating QMS elements (e.g., design controls, risk management, change control, supplier quality, complaint handling), and building regulator-ready narratives that anticipate agency questions. The result is fewer surprises, faster decisions, and a clearer path to market—reducing late-stage integration risk while improving time-to-market and total cost of quality.
No two combination products are alike. Success requires strategies designed for your molecule, delivery platform, and development stage. We work closely with your team to align regulatory pathways, integrate drug and device components, and build a roadmap that reduces risk and drives timely approval.
What you gain:
A client developing a wearable injector for chronic disease treatment asked us to lead their Human Factors program. We designed usability protocols, coordinated studies, and guided design refinements.
Impact for the client:
✔ FDA required HF validation testing passed
✔ Minimal redesign required
✔ NDA submission stayed on schedule
Combination products must meet requirements across CDER, CBER, and CDRH. Missteps can mean classification disputes, duplicate filings, or delayed approvals. We help you define your primary mode of action, structure dual pathway strategies where needed, and prepare for Part 4 compliance.
We shortened approval timelines by six months.
A biologic developer with an auto injector needed clarity across CDER and CDRH. We resolved classification ambiguities, led agency discussions, and mapped a dual pathway strategy.
Impact for the client:
✔ Regulatory alignment across CDER and CDRH
✔ Streamlined BLA and 510k submission
✔ Approval timelines reduced by six months
Combination products require harmonized quality systems that address both drug GMP (21 CFR 210 and 211) and device QSR (21 CFR 820). We help you design integrated systems that regulators recognize as robust and inspection ready.
Services you can rely on:
We launched on time with zero FDA findings.
A client preparing to launch an on body injector lacked an integrated QMS. We performed a gap analysis, created combination product SOPs, and aligned processes across drug and device partners.
Impact for the client:
✔ FDA inspection passed with no 483s
✔ QMS fully integrated across partners
✔ On body injector launched on schedule
From strategy through approval, we partner with you to overcome regulatory, quality, and technical barriers so you can bring safe and effective combination products to patients with confidence.
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
1.877.787.0177
510.732.0177
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
